Ultrasonic surgical instrument and cartilage and bone shaping blades therefor

ABSTRACT

An ultrasonic surgical blade that includes a blade body that has a treatment region. At least one indentation can be formed in the treatment region of the blade body wherein each indentation forms a tissue cutting edge with an outer surface of the blade body. The indentation may comprise one or more holes, lumens, grooves or dimples or a combination of such structures. In various embodiments, one or more aspiration lumens are provided in the surgical blade which may ultimately communicate with an aspiration lumen or passage in an ultrasonic surgical instrument.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to the following commonly-owned U.S.patent applications filed concurrently herewith, and which are herebyincorporated by reference in their entirety:

-   (1) U.S. patent application Ser. No. ______, entitled SURGICAL    INSTRUMENTS, Attny. Docket No. 060877/END6050USNP;-   (2) U.S. patent application Ser. No. ______, entitled ULTRASONIC    SURGICAL INSTRUMENTS, Atty. Docket No. 060878/END6051USNP; and-   (3) U.S. patent application Ser. No. ______, entitled SURGICAL    INSTRUMENTS, Atty. Docket No. 060879/END6052USNP.

FIELD OF THE INVENTION

The present invention relates, in general, to ultrasonic surgicalinstruments and, more particularly, to ultrasonic surgical instrumentsand blades configured for removing bone and/or shaping cartilage.

BACKGROUND OF THE INVENTION

During various orthopedic surgical procedures, it is often necessary toremove small layers of cortical bone. Several different tools have beendeveloped to accomplish this task and for preparing and/or shaping bonesurfaces. For example, mallets are often used to apply an impactingforce on a medical tool, such as a chisel, to remove pieces of bone.While mallets are somewhat effective, the impacting force must becarefully applied to avoid removal of too much bone or the inadvertentremoval of a wrong piece of bone. Moreover, the force applied to thechisel must be applied in a sufficiently accurate manner to avoid damageto adjacent tissues and/organs.

Other surgical tools known as burrs have also been developed forremoving layers of cortical bone and shaping bone and cartilage. Suchdevices, however, generally must be employed with high levels ofprecision to ensure that only the desired amount of bone is removed andthe surrounding tissues are not undesirably damaged or traumatized.These burrs and similar instruments, however, do not provide a means forcontrolling bleeding and tend to leave the treated tissue with aroughened surface. In an effort to address those problems, radiofrequency-based devices were developed.

Radio frequency-based devices enable surgeons to remove, modulate, orsculpt soft tissue while simultaneously sealing blood vessels. They workparticularly well on connective tissue, which is primarily comprised ofcollagen and which contracts when contacted by heat. However, such radiofrequency-based devices can create undesirable deep thermal injury inthe tissue.

Other instruments that have been developed for effectively cutting andcoagulating organic tissue employ mechanical vibrations that aretransmitted to a surgical end-effector at ultrasonic frequencies.Ultrasonic vibrations, when transmitted to organic tissue at suitableenergy levels and using a suitable end-effector, may be used to cut,dissect, elevate or cauterize tissue or to separate muscle tissue offbone. Ultrasonic instruments utilizing solid core technology areparticularly advantageous because of the amount of ultrasonic energythat may be transmitted from the ultrasonic transducer, through awaveguide, to the surgical end-effector.

Activating or exciting the end-effector (e.g., cutting blade) of suchinstruments at ultrasonic frequencies induces longitudinal vibratorymovement that generates localized heat within adjacent tissue,facilitating both cutting and coagulation. Because of the nature ofultrasonic instruments, a particular ultrasonically actuatedend-effector may be designed to perform numerous functions, including,for example, cutting and coagulation.

Ultrasonic vibration is induced in the surgical end effector byelectrically exciting a transducer, for example. The transducer may beconstructed of one or more piezoelectric or magnetostrictive elements inthe instrument hand piece. Vibrations generated by the transducersection are transmitted to the surgical end-effector via an ultrasonicwaveguide extending from the transducer section to the surgicalend-effector. The waveguides and end-effectors are designed to resonateat the same frequency as the transducer. Therefore, when an end-effectoris attached to a transducer the overall system frequency is the samefrequency as the transducer itself. Nevertheless, those skilled in theart will appreciate that the system may be designed where the transducerand the blade resonate at different frequencies and when joined thesystem resonates at a desired frequency.

The amplitude of the longitudinal ultrasonic vibration at the tip, d, ofthe end-effector behaves as a simple sinusoid at the resonant frequencyas given by:

d=A sin(ωt)

where:

-   ω=the radian frequency which equals 2π times the cyclic frequency,    f; and-   A=the zero-to-peak amplitude.    The longitudinal excursion is defined as the peak-to-peak (p-t-p)    amplitude, which is just twice the amplitude of the sine wave or 2A.

Over the years, a variety of different ultrasonic blade configurationshave been developed. Blades that tend to work well from a coagulationstandpoint (and hence change tissue into a sticky coagulum that can bereadily reshaped) do not tend to cut extremely well. Some of thoseblades generally have spherically-shaped body with a substantiallysmooth outer surface. FIGS. 2 and 3 depict a spherically-shaped blade 10of this type that has been used in the past. Such blade design, whileeffective from a coagulation standpoint, is not particularly well-suitedfor bone removal or tissue reshaping applications due to its shape.Other existing blades that are better adapted for cutting tissue, arenot as well-suited to coagulate and reshape tissue. These problems canbe further exacerbated in arthroscopic procedures that afford limitedaccess to the target tissue or bone and where the blade must work in anaqueous environment.

It would, therefore, be advantageous to design a harmonic surgicalinstrument for shaping either soft tissues such as cartilage or meniscusor for decorticating bone. It would be further advantageous to design aharmonic surgical instrument that can be used to decorticate andaspirate bone and also facilitate spot coagulation of tissue as well astissue reshaping. Various embodiments of the present inventionincorporate improvements to known ultrasonic instruments to providethese advantages. The foregoing discussion is intended only toillustrate some of the shortcomings present in the field of theinvention at the time, and should not be taken as a disavowal of claimscope.

SUMMARY

In one aspect of the invention, there is provided a surgical instrumentthat comprises an ultrasonic surgical blade that includes a blade bodythat has a treatment region. In various embodiments, at least oneindentation is formed in the treatment region of the blade body whereineach indentation forms a tissue cutting edge with an outer surface ofthe blade body.

In another general aspect of various embodiments of the presentinvention there is provided an ultrasonic surgical blade. In variousembodiments, the blade has a blade body that includes a substantiallyspherically-shaped treatment region. At least one substantially sharpedge can be formed on at least a portion of the spherically-shapedtreatment region.

In still another general aspect of various embodiments of the presentinvention there is provided an ultrasonic surgical instrument comprisingan ultrasonic transmission member that has a proximal end and a distalend and an ultrasonically actuated blade that is attached to the distalend of the transmission member. In various embodiments, the blade has ablade body that has a treatment region. At least one indentation can beformed in the treatment region of the blade body. Each indentation mayform a tissue cutting edge with an outer surface of the blade body.

These and other objects and advantages of the present invention shall bemade apparent from the accompanying drawings and the descriptionthereof.

BRIEF DESCRIPTION OF THE FIGURES

The novel features of the various embodiments of the invention are setforth with particularity in the appended claims. The various embodimentsof the invention, however, both as to organization and methods ofoperation, together with further objects and advantages thereof, maybest be understood by reference to the following description, taken inconjunction with the accompanying drawings in which:

FIG. 1 is a partial cross-sectional view of a surgical instrument ofvarious embodiments of the present invention;

FIG. 2 is a partial perspective view of a portion of a prior ultrasonicsurgical blade;

FIG. 3 is a elevational view of the distal end of the prior bladedepicted in FIG. 2;

FIG. 4 is a perspective view of a portion of an ultrasonic surgicalblade embodiment of the present invention;

FIG. 5 is an elevational view of a distal end of the ultrasonic surgicalblade of FIG. 4;

FIG. 6 is a cross-sectional view of the portion of the ultrasonic bladedepicted in FIGS. 4 and 5 taken along line 6-6 in FIG. 5;

FIG. 7 is a perspective view of a portion of another ultrasonic surgicalblade embodiment of the present invention;

FIG. 8 is an elevational view of a distal end of the ultrasonic surgicalblade of FIG. 7;

FIG. 9 is a cross-sectional view of the portion of the ultrasonic bladedepicted in FIGS. 7 and 8 taken along line 9-9 in FIG. 8;

FIG. 10 is a perspective view of a portion of another ultrasonicsurgical blade embodiment of the present invention;

FIG. 11 is an elevational view of a distal end of the ultrasonicsurgical blade of FIG. 10;

FIG. 12 is a cross-sectional view of the portion of the ultrasonic bladedepicted in FIGS. 10 and 11 taken along line 12-12 in FIG. 11;

FIG. 13 is a perspective view of a portion of another ultrasonicsurgical blade embodiment of the present invention;

FIG. 14 is an elevational view of a distal end of the ultrasonicsurgical blade of FIG. 13;

FIG. 15 is a cross-sectional view of the portion of the ultrasonic bladedepicted in FIGS. 13 and 14 taken along line 15-15 in FIG. 14;

FIG. 16 is a perspective view of a portion of another ultrasonicsurgical blade embodiment of the present invention;

FIG. 17 is a top view of the ultrasonic surgical blade of FIG. 16;

FIG. 18 is a perspective view of a portion of another ultrasonicsurgical blade embodiment of the present invention;

FIG. 19 is an elevational view of a distal end of the ultrasonicsurgical blade of FIG. 18;

FIG. 20 is a cross-sectional view of the portion of the ultrasonic bladedepicted in FIGS. 18 and 19 taken along line 20-20 in FIG. 19;

FIG. 21 is a perspective view of a portion of another ultrasonicsurgical blade embodiment of the present invention;

FIG. 22 is a top view of the portion of the ultrasonic blade of FIG. 21;

FIG. 23 is a top view of a portion of another ultrasonic surgical bladeembodiment of the present invention; and

FIG. 24 is an elevational view of a distal end of the ultrasonicsurgical blade of FIG. 23.

DETAILED DESCRIPTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments ofthe invention may be implemented or incorporated in other embodiments,variations and modifications, and may be practiced or carried out invarious ways. For example, the surgical instrument and bladeconfigurations disclosed below are illustrative only and not meant tolimit the scope or application of the invention. Furthermore, unlessotherwise indicated, the terms and expressions employed herein have beenchosen for the purpose of describing the illustrative embodiments of thepresent invention for the convenience of the reader and are not for thepurpose of limiting the invention.

Various embodiments of the present invention relate, in general, toultrasonic surgical blades for use with ultrasonic surgical instrumentsand, more particularly, to ultrasonic surgical blades and instrumentsfor improved bone and tissue removal, aspiration, and coagulationfeatures. A blade according to various embodiments of the presentinvention may be of particular benefit in orthopedic procedures whereinit is desirable to remove cortical bode and/or tissue while controllingbleeding. A variety of different blade configurations are disclosedwhich may be useful for both open and laparoscopic applications.

Examples of ultrasonic surgical instruments are disclosed in U.S. Pat.Nos. 5,322,055 and 5,954,736 and in combination with ultrasonic bladesand surgical instruments as, for example, disclosed in U.S. Pat. Nos.6,309,400 B2, 6,278,218B1, 6,283,981 B1, and 6,325,811 B1 all of whichare incorporated in their entirety by reference herein. These referencesdisclose ultrasonic surgical instrument design and blade designs where alongitudinal anti-node of the blade is excited. Because of asymmetry orasymmetries, these blades exhibit transverse and/or torsional motionwhere the characteristic “wavelength” of this non-longitudinal motion isless than that of the general longitudinal motion of the blade and itsextender portion. Therefore, the wave shape of the non-longitudinalmotion will present nodal positions of transverse/torsional motion alongthe tissue effector while the net motion of the active blade along itstissue effector is non-zero (i.e. will have at least longitudinal motionalong the length extending from its distal end, an antinode oflongitudinal motion, to the first nodal position of longitudinal motionthat is proximal to the tissue effector portion). Those of ordinaryskill in the art will also appreciate that the combination of transverseand/or torsional motions in combination with the longitudinal motioncould augment the cutting action. Certain exemplary embodiments will nowbe described to provide an overall understanding of the principles ofthe structure, function, manufacture, and use of the devices and methodsdisclosed herein. One or more examples of these embodiments areillustrated in the accompanying drawings. Those of ordinary skill in theart will understand that the devices and methods specifically describedherein and illustrated in the accompanying drawings are non-limitingexemplary embodiments and that the scope of the various embodiments ofthe present invention is defined solely by the claims. The featuresillustrated or described in connection with one exemplary embodiment maybe combined with the features of other embodiments. Such modificationsand variations are intended to be included within the scope of thepresent invention.

FIG. 1 illustrates ultrasonic system 10 comprising an ultrasonic signalgenerator 12 with ultrasonic transducer 14, hand piece housing 16, andblade 100 in accordance with the present invention. The ultrasonictransducer 14, which is known as a “Langevin stack”, generally includesa transduction portion 18, a first resonator or end-bell 20, and asecond resonator or fore-bell 22, and ancillary components. Theultrasonic transducer 14 is preferably an integral number of one-halfsystem wavelengths (nλ/2) in length as will be described in more detaillater. An acoustic assembly 24 includes the ultrasonic transducer 14,mount 26, velocity transformer 28 and surface 30.

The distal end of end-bell 20 is connected to the proximal end oftransduction portion 18, and the proximal end of fore-bell 22 isconnected to the distal end of transduction portion 18. Fore-bell 22 andend-bell 20 have a length determined by a number of variables, includingthe thickness of the transduction portion 18, the density and modulus ofelasticity of the material used to manufacture end-bell 20 and fore-bell22, and the resonant frequency of the ultrasonic transducer 14. Thefore-bell 22 may be tapered inwardly from its proximal end to its distalend to amplify the ultrasonic vibration amplitude as velocitytransformer 28, or alternately may have no amplification.

The transducer may be constructed of one or more piezoelectric ormagnetostrictive elements in the instrument hand piece. Ultrasonicvibration is induced in the surgical end-effector by, for example,electrically exciting a transducer which may be constructed of one ormore piezoelectric or magnetostrictive elements in the instrumenthand-piece. Vibrations generated by the transducer section aretransmitted to the surgical end-effector via an ultrasonic waveguideextending from the transducer section to the surgical end-effector.

In the illustrated embodiment, the transducer is constructed withpiezoelectric elements 40. The piezoelectric elements 40 may befabricated from any suitable material, such as, for example, leadzirconate-titanate, lead meta-niobate, lead titanate, or otherpiezoelectric crystal material. Each of the positive electrodes 42,negative electrodes 44, and piezoelectric elements 40 has a boreextending through the center. The positive and negative electrodes 42and 44 are electrically coupled to wires 46 and 48, respectively. Wires46 and 48 are encased within cable 50 and electrically connectable toultrasonic signal generator 12 of ultrasonic system 10.

Ultrasonic transducer 14 of the acoustic assembly 24 converts theelectrical signal from ultrasonic signal generator 12 into mechanicalenergy that results in primarily longitudinal vibratory motion of theultrasonic transducer 14 and blade 100 at ultrasonic frequencies. Asuitable generator is available as model number GEN04, from EthiconEndo-Surgery, Inc., Cincinnati, Ohio. When the acoustic assembly 24 isenergized, a vibratory motion standing wave is generated through theacoustic assembly 24. The amplitude of the vibratory motion at any pointalong the acoustic assembly 24 may depend upon the location along theacoustic assembly 24 at which the vibratory motion is measured. Aminimum or zero crossing in the vibratory motion standing wave isgenerally referred to as a node (i.e., where motion is usually minimal),and an absolute value maximum or peak in the standing wave is generallyreferred to as an anti-node. The distance between an anti-node and itsnearest node is one-quarter wavelength (λ/4).

Wires 46 and 48 transmit the electrical signal from the ultrasonicsignal generator 12 to positive electrodes 42 and negative electrodes44. The piezoelectric elements 40 are energized by an electrical signalsupplied from the ultrasonic signal generator 12 in response to a footswitch 60 to produce an acoustic standing wave in the acoustic assembly24. The electrical signal causes disturbances in the piezoelectricelements 40 in the form of repeated small displacements resulting inlarge compression forces within the material. The repeated smalldisplacements cause the piezoelectric elements 40 to expand and contractin a continuous manner along the axis of the voltage gradient, producinglongitudinal waves of ultrasonic energy. The ultrasonic energy istransmitted through the acoustic assembly 24 to the blade 100.

In order for the acoustic assembly 24 to deliver energy to the blade100, all components of acoustic assembly 24 must be acoustically coupledto the blade 100. The distal end of the ultrasonic transducer 14 may beacoustically coupled at surface 30 to the proximal end of an ultrasonicwaveguide 80 by a threaded connection such as stud 90.

The components of the acoustic assembly 24 are preferably acousticallytuned such that the length of any assembly is an integral number ofone-half wavelengths (nλ/2), where the wavelength λ is the wavelength ofa pre-selected or operating longitudinal vibration drive frequency f_(d)of the acoustic assembly 24, and where n is any positive integer. It isalso contemplated that the acoustic assembly 24 may incorporate anysuitable arrangement of acoustic elements.

In addition, an aspiration transducer may be provided, such as aphaco-emulsifier, includes a central lumen in the transducer to allowfor aspiration of tissue and fluids through the back of the transducer.The central lumen may be inserted through an incision and vibratesultrasonically to liquefy tissue. The emulsified tissue is removed byaspiration via the lumen through the back of the transducer. Modernaspirators also perform irrigation. These irrigation/aspirationinstruments have dual passages or lumens, one for irrigation and theother for aspiration. Usually the passages are coaxial, the innerpassage being formed by a rigid or semi-rigid cannula, and the outerpassage having a distal portion formed by a sleeve which may beresilient. One or more components of the tips are removable from thehandpiece of the instrument for selection of an appropriate or desiredtip, and for replacement of the tip.

FIGS. 4-6 illustrate one ultrasonic surgical blade embodiment of thepresent invention that may be employed with the above-describedultrasonic instrument 10. However, as the present detailed descriptionproceeds, those of ordinary skill in the art will understand that thevarious ultrasonic surgical blade embodiments that are disclosed hereinas well as any equivalent structures thereof could conceivably beeffectively used in connection with other known ultrasonic surgicalinstruments without departing from the spirit and scope of the presentinvention. Thus, the protection afforded to the various ultrasonicsurgical blade embodiments disclosed herein should not be limited to useonly in connection with the exemplary ultrasonic surgical instrumentdescribed above.

As can be seen in FIGS. 4-6, the ultrasonic surgical blade 100 has ablade body 110 that has a generally smooth exterior surface 122 that iswell-suited for coagulation and tissue reshaping applications. Thesmooth exterior surface is well-suited for coagulation of tissue due tothe ability to place a large blunt surface that is ultrasonically activeagainst the tissue. This allows for the transfer of heat without therisk of cutting, allowing the tissue to form into a sticky coagulum thatseals vessels. The blade 100 may be fabricated from a material suitablefor transmission of ultrasonic energy such as, for example, Ti6Al4V ( analloy of Titanium including Aluminum and Vanadium), Aluminum, StainlessSteel, or other known materials. The blade body 110 may comprise asubstantially spherically-shaped treatment region, generally designatedas 120, and a neck or transition portion 130 that protrudes from aproximal portion 121 of the treatment region 120. As indicated above,the neck portion 130 may be attached to the waveguide 80 by, forexample, a stud, welding, gluing, or other known methods. In alternativeembodiments, the neck portion 130 and waveguide 80 may comprise a singleunit. The ultrasonic waveguide 80 may, for example, have a lengthsubstantially equal to an integral number of one-half system wavelengths(λ/2). The ultrasonic waveguide 80 may be preferably fabricated from asolid core shaft constructed out of material that propagates ultrasonicenergy efficiently, such as titanium alloy (i.e., Ti-6Al-4V) or analuminum alloy, for example. The ultrasonic waveguide 80 may also beconfigured to amplify the mechanical vibrations transmitted to theultrasonic blade 100 as is well known in the art.

In alternative embodiments the ultrasonic transmission waveguide may befabricated with a hollow core. In other embodiments, the ultrasonicsurgical blade may comprise an outer sheath that protects patienttissues from the ultrasonic transmission waveguide. In such embodiment,a lumen may be provided in the longitudinal extending space between theouter sheath and the surgical blade. The lumen may be employed toirrigate or aspirate tissue trough through the lumen located between theblade and the outer sheath.

The ultrasonic blade 100 may have a length substantially equal to anintegral multiple of one-half system wavelengths (λ/2). The distal endof ultrasonic blade 100 is disposed near an antinode in order to providethe maximum longitudinal excursion of the distal end. When thetransducer assembly is energized, the distal end 124 of the ultrasonicblade 100 may be configured to move in the range of, for example,approximately 10 to 150 microns peak-to-peak, and preferably in therange of about 30 to 150 100 microns at a predetermined vibrationalfrequency of 55.5 kHz. The ultrasonic blade 100 may be configured tovibrate with an amplitude at a specified frequency that creates a bladevelocity of between 2 meters/sec and 30 meters/sec.

While the treatment region in this exemplary embodiment is substantiallyspherical in shape, those of ordinary skill in the art will appreciatethat the blade body 110 may be provided in other shapes that provide asubstantially smooth and rounded outer perimeter. For example, the bladebody could comprise a slightly elongated cylinder-like member with arounded distal end.

Referring to FIG. 1, in various embodiments, an aspiration lumen 140 maybe provided through the treatment region 120 and neck portion 130 and beconfigured to ultimately communicate with a stand alonesuction/irrigation module, tower mounted suction 90 and/or irrigation 92modules (FIG. 1), or an integrated ultrasonicgenerator/suction/irrigation module in the operating room, for example.It may also be advantageous to integrate suction/irrigation controls(i.e. trumpet valves, etc.) and a means for selecting either suction orirrigation functions within the device handle.

As can be seen in FIGS. 4 and 6, the aspiration lumen 140 can form anopening 150 in the distal end 124 of the treatment region 120. Invarious embodiments, the opening 150 is defined by an tissue cuttingedge 152 formed in the outer surface 122 of the treatment region 120.Cutting edge 152 can be used to cut and reshape tissue and it may alsoserve as a bearing surface or edge for removing cortical bone. As thetissue and/or bone material is cut away or dislodged by cutting edge152, the material can be removed from the surgical field through thelumen 140 and the aspiration passage in the surgical instrument. In atleast one embodiment, the spherically-shaped treatment region 110 andrelative smooth perimetrical outer surface 122 are well-suited forcoagulating and reshaping tissue. More particularly, owing to thesubstantially spherically shaped surface 122, surface 122 can be used toheat and manipulate tissue, for example, without cutting it such that,when the tissue cools, the tissue can maintain its reconfigured shape.The edge 152 may also provide the surgeon with a means for cutting andshaping tissue and dislodging pieces of bone which represents a vastimprovement of prior spherically-shaped ultrasonic blades. Thisembodiment also provides the added feature of being able to aspirate thesurgical field and to remove tissue and small pieces of bone therefrom.

FIGS. 7-9 illustrate another ultrasonic surgical blade 200 of thepresent invention. As can be seen in those Figures, the blade 200 has ablade body 210 that has a relative smooth outer surface 222 and may befabricated from any of the materials described above. The blade body 210may comprise a substantially spherically-shaped treatment region,generally designated as 220 and a neck or transition portion 230 thatprotrudes from a proximal portion 221 of the treatment region 220. Theneck portion 230 may be attached to a waveguide (not shown) by, forexample, a stud, welding, gluing, or other known methods. In alternativeembodiments, the neck portion 230 and waveguide may comprise a singleunit.

In various embodiments, an aspiration lumen 240 may be provided throughthe treatment region 220 and neck portion 230 and ultimately communicatewith a stand alone suction/irrigation module, tower mounted suction 90and/or irrigation 92 modules (FIG. 1), or an integrated ultrasonicgenerator/suction/irrigation module in the operating room, for example.Those of ordinary skill in the art will understand that the suctionmodule may be employed to aspirate tissue and fluids away from thesurgical site and the irrigation module may be used to supply irrigationfluids to the surgical site. In the present embodiment, the aspirationlumen 240 has a tapered portion 242 that forms an opening 250 in thedistal end 224 of the treatment region 220. The opening 250 is definedby a tissue cutting edge 252 formed in the outer surface 222 of thetreatment region 220 that can be used to form and reshape tissue andalso assist in the removal of cortical bone. In various embodiments,edge 252 may be relatively sharp to assist in the removal of tissueand/or bone. As the tissue and/or bone material is cut away ordislodged, it can be removed from the surgical field through theaspiration lumen 240. One advantage of the tapered portion is that itinitially allows for an acute angle at the ball surface, creating a muchsharper edge than a straight bore. In addition, the tapered portion 272narrows the cutting hole to minimize the size of the particles generatedby cutting. This increases the likelihood that the size of the particlesis smaller than the central lumen and thus minimizing the likelihoodthat they will become stuck in the lumen.

In alternative embodiments, the tapered portion 272 may be fabricatedfrom a material that has a property or properties that differ from theproperty/properties of the material from which the blade body 210 isfabricated. For example, such tapered portion 272 may be pressed intothe lumen 240 and/or otherwise attached in position by welding, threads,or other suitable fastener arrangements. In various embodiments, thesecond material may be selected based on its tensile strength, fatiguestrength and/or its ability to maintain an edge or other desirableproperties.

FIGS. 10-12 illustrate another ultrasonic surgical blade 300 of thepresent invention. As can be seen in those Figures, the blade 300 has ablade body 310 that has a relatively smooth outer surface 322 and may befabricated from any of the materials described above. The blade body 310may comprise a substantially spherically-shaped treatment region,generally designated as 320. A neck or transition portion 330 protrudesfrom a proximal portion 321 of the treatment region 320. The neckportion 330 may be attached to a waveguide (not shown) by, for example,a stud, welding, gluing, or other known methods. In alternativeembodiments, the neck portion 330 and waveguide may comprise a singleunit.

In various embodiments, a first aspiration lumen 340 may be provided inthe treatment region 320 and neck portion 330 along a longitudinal axisA-A which ultimately communicates with a stand alone suction/irrigationmodule, tower mounted suction 90 and/or irrigation 92 modules (FIG. 1),or an integrated ultrasonic generator/suction/irrigation module in theoperating room, for example. In the present embodiment, the firstaspiration lumen 340 intersects a second aspiration lumen 342 in thetreatment region 320 that lies along an axis B-B that intersects axisA-A. In various embodiments, axis B-B may be substantially perpendicularto axis A-A as shown in FIGS. 10 and 12. The second aspiration lumen 342may form two diametrically opposed openings 344, 346 in the treatmentregion 320. In the present embodiment, opening 344 is defined by an edge345 and opening 346 is defined by an edge 347. Edges 345, 347 can beused to form and reshape tissue and also assist in the removal ofcortical bone. In various embodiments, one or both edges 345, 347 may berelatively sharp to assist in the removal of tissue and/or bone. As thetissue and/or bone material is cut away or dislodged by edges 345, 347,the material can be removed from the surgical field through the lumens340 and 342. In alternative embodiments, one or both of openings 344,346 may be formed with a tapered portion of the arrangements describedabove.

FIGS. 13-15 illustrate another ultrasonic surgical blade 400 of thepresent invention. As can be seen in those Figures, the blade 400 has ablade body 410 that has a relatively smooth outer surface 422 and may befabricated from any of the materials described above. The blade body 410may comprise a substantially spherically-shaped treatment region,generally designated as 420. In this embodiment, an endless groove 450is provided around the circumference of the treatment region 420. Thegroove 450 may have a rounded bottom as shown or it may have a pointedbottom, square bottom, etc. In the illustrated embodiment, thecircumferentially extending endless groove 450 forms two parallel edges452, 454 in the otherwise substantially smooth outer surface 422 forcutting and forming tissue and for providing a bearing surface to removebone and tissue. A neck or transition portion 430 can protrude from aproximal portion 421 of the treatment region 420. The neck portion 430may be attached to a waveguide (not shown) by, for example, a stud,welding, gluing, or other known methods. In alternative embodiments, theneck portion 430 and waveguide may comprise a single unit.

In various embodiments, an aspiration lumen 440 may be provided in thetreatment region 420 and neck portion 430 which ultimately communicateswith a stand alone suction/irrigation module, tower mounted suction 90and/or irrigation 92 modules (FIG. 1), or an integrated ultrasonicgenerator/suction/irrigation module in the operating room, for example.In this embodiment, at least one, but preferably two, cross lumens 442,444 can extend from the closed end 441 of lumen 440 in diametricallyopposed directions and open into the endless groove 450 as shown. As thetissue and/or bone material is cut away or dislodged by edges 452, 454,the material can be removed from the surgical field through the lumens444, 442, and 440. In the embodiment depicted in FIGS. 13-15, oneendless groove 450 is shown. In the illustrated embodiment, the grooveextends around the circumference such that it is substantiallyperpendicular to the neck. In other embodiments, one or more grooves maybe formed around body such that they are not perpendicular to the neckportion—e.g., they extend vertically. In alternative embodiments, aplurality of endless grooves may be employed. In still otherembodiments, a plurality of discrete grooves may be provided in therelatively smooth outer surface 412. Those discrete grooves may bearranged along substantially parallel axes or they may be axiallyaligned along a single axis. Those of ordinary skill in the art willalso understand that one, two, or more than two cross-lumens may beemployed. Such cross lumens may either open into a groove or the outersurface 422 and also open into the aspiration lumen 430. In still otherembodiments, one or more cross-lumens may open into a groove and one ormore other cross-lumens may open through the surface 422. Those ofordinary skill in the art will understand that, in those embodimentswherein only one cross lumen is employed, such arrangement may result inan imbalance in the blade that may also generate some desirabletransverse motions. In still other embodiments wherein only onecross-lumen is employed, such “primary” imbalance caused by only asingle cross-lumen may be neutralized by a cavity or similar area (a“secondary” imbalance) provided in another portion of the blade or thecross-lumen could be made small enough to minimize any imbalance createdthereby. In other embodiments as shown in FIGS. 16 and 17, no lumens areprovided in blade body 410.

FIGS. 18-20 illustrate another ultrasonic surgical blade 500 of thepresent invention. As can be seen in those Figures, the blade 500 has ablade body 510 that has a relatively smooth outer surface 522 and may befabricated from any of the materials described above. The blade body 510may comprise a substantially spherically-shaped treatment region,generally designated as 520. In this embodiment, at least one discreethole 550 is provided in the treatment region 520. In the embodimentshown in FIGS. 18-20, four holes 550 are shown. In various embodiments,the number and arrangement of holes 550 may vary. Each hole 550 can forman opening 552 in the treatment region 520 that forms a tissue cuttingedge 554 in the outer surface 422 that can be used to form and reshapetissue and also assist in the removal of cortical bone. The holes 550may have a flat bottom 555 as shown or the bottoms may be rounded,pointed, etc. One or more of the holes 550 may have a tapered portion551 to further facilitate formation of a sharpened edge 554. In theillustrated embodiment, a neck or transition portion 430 can protrudefrom a proximal portion 521 of the treatment region 520. The neckportion 530 may be attached to a waveguide (not shown) by, for example,a stud, welding, gluing, or other known methods. In alternativeembodiments, the neck portion 430 and waveguide may comprise a singleunit.

FIGS. 21 and 22 illustrate another ultrasonic surgical blade 600 of thepresent invention. As can be seen in those Figures, the blade 600 has ablade body 610 that has a relatively smooth outer surface 622 and may befabricated from any of the materials described above. The blade body 610may comprise a substantially spherically-shaped treatment region,generally designated as 620. In this embodiment, at least one dimple 650is provided in the treatment region 620. In the embodiment shown inFIGS. 21 and 22, four dimples 650 are shown. In various embodiments, thenumber and arrangement of dimples 650 may vary. Each dimple 650 can forma tissue cutting edge 652 in the exterior surface 622 that can be usedto form and reshape tissue and also assist in the removal of corticalbone. In the illustrated embodiment, a neck or transition portion 630protrudes from a proximal portion of the treatment region 620. The neckportion 630 may be attached to a waveguide (not shown) by, for example,a stud, welding, gluing, or other known methods. In alternativeembodiments, the neck portion 630 and waveguide may comprise a singleunit.

FIGS. 23 and 24 illustrate another ultrasonic surgical blade 700 of thepresent invention. As can be seen in those Figures, the blade 700 has abody 710 that has a rounded distal end 712 and two relatively planarsurfaces 714 and 716 that are separated by a side surface 718. Blade 700may be fabricated from any of the materials described above. The body710 may comprise a treatment region, generally designated as 720. Inthis embodiment, at least one hole 750 is provided in the side 718 ofthe body 710. In the embodiment shown in FIGS. 23 and 24, three holes750 are shown. In various embodiments, the number and arrangement ofholes 750 may vary. Each hole 750 can form an opening 752 in the bodyportion 710 that forms an edge 754 that can be used to form and reshapetissue and also assist in the removal of cortical bone. In oneembodiment, the holes 750 may be in fluid communication with a centrallumen for irrigation and aspiration of tissue during cutting. The holes750 may have a flat bottom 755 as shown or the bottoms may be rounded,pointed, etc. In the illustrated embodiment, a neck or transitionportion 730 protrudes from a proximal portion of the treatment region720. The neck portion 730 may be attached to a waveguide (not shown) by,for example, a stud, welding, gluing, or other known methods. Inalternative embodiments, the neck portion 730 and waveguide may comprisea single unit.

The various embodiments of the present invention described herein, aswell as their equivalent structures, represent a vast improvement overprior ultrasonic surgical blade configurations. For example, several ofthe embodiments disclosed herein include a treatment region that issubstantially spherical in shape and has a relatively smooth outersurface which can be advantageously employed to coagulate and reshapetissue. In addition, several of the embodiments disclosed herein haveone or more tissue cutting edges formed in the treatment region thereofwhich can be used to cut and shave tissue and may also serve as bearingsurfaces that can be used to engage and remove portions of cortical bonewhen an impact force is applied to the instrument by conventional means(mallet, etc.). These edges may be advantageously sharpened utilizingfiles or other conventional sharpening tools or, if desired, the edgesmay be relatively dull. A variety of different structures have beendisclosed for forming the edges in the otherwise smooth exterior surfaceof the body portion. In general, the edges may be formed by indentationsin the outer surface of the body portion. As used in this context, theterm “indentation” may comprise, for example, a discrete hole (i.e., ahole that does not pass completely through any portion of the body), alumen or passageway that forms an opening in the outer surface andpasses through the body member, a groove or series of grooves formed inthe outer surface of the body portion, dimples and/or any combination ofthese indentations. The number and orientations of such “indentations”may vary without departing from the spirit and scope of the presentinvention and provided that a desired amount of relatively smoothsurface is maintained for coagulation and tissue shaping purposes.

Thus, as can be appreciated form the foregoing, various embodiments ofthe present invention provide a faster and more precise method forremoving cortical bone. Such arrangements may also require less force toremove bone than prior bone removal methods. In addition, the unique andnovel features of various embodiments of the present invention alsofacilitate spot coagulation of tissue with out the need to use radiofrequency-based means which can create deep thermal injury to thetissue.

While several embodiments of the invention have been described, itshould be apparent, however, that various modifications, alterations andadaptations to those embodiments may occur to persons skilled in the artwith the attainment of some or all of the advantages of the invention.For example, according to various embodiments, a single component may bereplaced by multiple components, and multiple components may be replacedby a single component, to perform a given function or functions. Thisapplication is therefore intended to cover all such modifications,alterations and adaptations without departing from the scope and spiritof the disclosed invention as defined by the appended claims.

The blades and devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. In either case, however, the device may be reconditioned forreuse after at least one use. Reconditioning can include an combinationof the steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, the device may be disassembled, and any number of particularpieces or parts of the device can be selectively replaced or removed inany combination. Upon cleaning and/or replacement of particular parts,the device may be reassembled for subsequent use either at areconditioning facility, or by a surgical team immediately prior to asurgical procedure. Those of ordinary skill in the art will appreciatethat the reconditioning of a device may utilize a variety of differenttechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First a new or used instrument is obtained and, if necessary,cleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK® bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or higher energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that the device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam, autoclaving, soaking in sterilizationliquid, or other known processes.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

The invention which is intended to be protected is not to be construedas limited to the particular embodiments disclosed. The embodiments aretherefore to be regarded as illustrative rather than restrictive.Variations and changes may be made by others without departing from thespirit of the present invention. Accordingly, it is expressly intendedthat all such equivalents, variations and changes which fall within thespirit and scope of the present invention as defined in the claims beembraced thereby.

1. An ultrasonic surgical blade comprising: a blade body having antreatment region; and at least one indentation formed in said treatmentregion of said blade body wherein each said indentation forms a tissuecutting edge with an outer surface of said blade body.
 2. An ultrasonicsurgical blade according to claim 1 wherein said at least oneindentation is selected from the group consisting of holes, lumens,grooves, and dimples.
 3. An ultrasonic surgical blade according to claim2 wherein said grooves comprise a series of groove segments.
 4. Anultrasonic surgical blade according to claim 1 wherein said treatmentregion is substantially spherically-shaped.
 5. An ultrasonic surgicalblade according to claim 1 wherein said at least one indentationcomprises a hole that has a tapered portion that forms said tissuecutting edge with said outer surface of said blade body.
 6. Anultrasonic surgical blade according to claim 5 wherein said blade bodyis fabricated from a first material and wherein said tapered portion isfabricated from a second material that differs from said first material.7. An ultrasonic surgical blade according to claim 1 wherein said atleast one indentation comprises a lumen extending through said bladebody, said lumen forming an opening through an outer surface of saidblade body such that a perimeter of said opening forms said tissuecutting edge.
 8. An ultrasonic surgical blade according to claim 1wherein said at least one indentation comprises a lumen extendingthrough said blade body, said lumen having a tapered distal end thatforms an opening in said treatment region that forms said tissue cuttingedge with said outer surface of said blade body.
 9. An ultrasonicsurgical blade according to claim 1 further comprising: a neck portionprotruding from a portion of said treatment region along a longitudinalaxis; a first lumen extending through a portion of said blade body andsaid neck portion; and at least one second lumen extending throughanother portion of said blade body and intersecting said first lumen forfluid communication therewith, each said second lumen forming at leastone opening through an outer surface of said blade body, each saidopening forming a tissue cutting edge with said outer surface.
 10. Anultrasonic surgical blade according to claim 9 wherein said at least onesecond lumen forms diametrically opposed openings through said outersurface of said blade body.
 11. An ultrasonic surgical blade accordingto claim 9 wherein said at least one indentation comprises at least onegroove in said outer surface of said blade body and wherein said groovecommunicates with at least one said opening.
 12. An ultrasonic surgicalblade according to claim 9 wherein said at least one second lumenextends along an axis that is substantially perpendicular to saidlongitudinal axis.
 13. An ultrasonic surgical blade according to claim 1wherein said at least one indentation comprises at least one lumenformed in said blade body and forming at least one opening through anouter surface of said blade body such that a perimeter of said openingforms said tissue cutting edge, said at least one lumen forming aprimary imbalance in said blade body.
 14. An ultrasonic blade accordingto claim 13 further comprising a second imbalance formed in said bladebody offsetting said primary imbalance.
 15. An ultrasonic surgical bladeaccording to claim 7 further comprising an aspiration membercommunicating with said at least one lumen.
 16. An ultrasonic surgicalblade according to claim 7 wherein said at least one lumen is in fluidcommunication with at least one of an aspiration module and anirrigation module.
 17. A method for processing an ultrasonic surgicalblade for surgery, the method comprising: obtaining the ultrasonicsurgical blade of claim 1; sterilizing the ultrasonic surgical blade;and storing the ultrasonic surgical blade in a sterile container.
 18. Anultrasonic surgical blade comprising: a blade body having asubstantially spherically-shaped treatment region; and at least onesubstantially sharp edge formed on at least a portion of saidspherically-shaped treatment region.
 19. An ultrasonic surgical bladeaccording to claim 18 wherein said at least one substantially sharp edgecomprises at least one endless sharp edge formed by a groove in saidsubstantially spherically-shaped treatment region.
 20. An ultrasonicsurgical blade according to claim 18 further comprising at least onelumen passage in said blade body.
 21. An ultrasonic surgical bladeaccording to claim 20 wherein said at least one lumen passage forms animbalance in said blade body.
 22. An ultrasonic surgical blade accordingto claim 21 further comprising an aspiration member communicating withsaid at least one lumen passage.
 23. An ultrasonic surgical bladeaccording to claim 22 wherein said at least one lumen passage is influid communication with at least one of an aspiration module and anirrigation module.
 24. An ultrasonic surgical blade according to claim21 wherein said at least one lumen passage opens into said groove. 25.An ultrasonic surgical blade according to claim 18 further comprising atleast one lumen passage in said substantially spherically-shapedtreatment region and wherein said at least one substantially sharp edgeis formed wherein a tapered portion of said lumen passage opens througha distal end of said substantially spherically-shaped treatment region.26. An ultrasonic surgical blade according to claim 18 furthercomprising at least one hole in said substantially spherically shapedtreatment region wherein said at least one substantially sharp edge isformed by a tapered portion of said hole that opens through an outersurface of said substantially spherically-shaped treatment region. 27.An ultrasonic surgical instrument comprising: an ultrasonic transmissionmember having a proximal end and a distal end; and an ultrasonicallyactuated blade attached to the distal end of the ultrasonic transmissionmember, wherein the blade comprises: a blade body having an treatmentregion; and at least one indentation formed in said treatment region ofsaid blade body wherein each said indentation forms a tissue cuttingedge with an outer surface of said blade body.
 28. An ultrasonicsurgical instrument according to claim 27 wherein said at least oneindentation is selected from the group consisting of holes, lumens,grooves, and dimples.
 29. An ultrasonic surgical instrument according toclaim 27 wherein said treatment region is substantiallyspherically-shaped.
 30. An ultrasonic surgical instrument according toclaim 27 wherein said ultrasonic transmission member is configured totransmit at least one of a longitudinal motion, transverse motion andtorsional motion from a corresponding source of said longitudinalmotion, transverse motion, and torsional motion communicating therewithto said ultrasonically actuated blade.
 31. The ultrasonic surgicalinstrument according to claim 30 wherein said ultrasonic transmissionmember is configured to transmit a combination of said longitudinalmotion, transverse motion and torsional motion to said ultrasonicallyactuated blade.
 32. A method for processing an ultrasonic surgicalinstrument, the method comprising: obtaining the ultrasonic surgicalinstrument of claim 27; detaching the ultrasonically actuated blade fromthe distal end of the ultrasonic transmission member of the ultrasonicsurgical instrument; and performing one of the following actions:reforming at least one of the indentations in the blade body,resterilizing the ultrasonically actuated blade and reattaching theresterilized blade to the distal end of the ultrasonic transmissionmember; or attaching another sterilized ultrasonically actuated blade tothe distal end of the ultrasonic surgical instrument.
 33. A method ofmounting an ultrasonic surgical blade according to claim 1 onto a distalend of an ultrasonic transmission member, said method comprising one ofthe actions selected from the group of actions consisting of welding,threading and gluing.